FL
Technical writer
Fusion Life Sciences
US · On-site Full-time 1w ago
About the role
Responsibilities
The Technical Writer will support a document remediation workstream focused on updating and retiring documents within the Veeva QualityDocs Electronic Document Management System (EDMS). This includes executing document revisions and retirements based on Subject Matter Expert (SME) direction to ensure alignment with facility closure activities.
- Retire obsolete and superseded documents within Veeva QualityDocs
- Execute simple document revisions based on SME guidance, including removal of references to the facility
- Remove sections related to discontinued or transferred products
- Update headers, footers, titles, and applicability statements to align with current standards
- Apply updates using redlines, direct document edits, and formatting changes per current templates
- Initiate and submit document change control records for review and approval
- Ensure compliance with internal quality standards and regulated documentation practices
- Submit updates for impacted training materials (e.g., quizzes and on-the-job training) within the Learning Management System (LMS)
- Manage document workflows to meet project timelines and ensure timely completion of assigned tasks
- Collaborate with SMEs and cross-functional teams to ensure accuracy and completeness of document updates
Qualifications
- Experience in a regulated pharmaceutical or biotechnology environment
- Hands-on experience with electronic document management systems (EDMS); Veeva QualityDocs strongly preferred
- Minimum of 2+ years of technical writing or document control experience
- Experience executing document revisions, formatting, and retirements under structured guidance
- Familiarity with document change control processes and training systems (LMS)
- Strong attention to detail and ability to follow defined processes and SME direction
- Excellent written and verbal communication skills with the ability to work in a fast-paced, team-oriented environment
- Ability to manage multiple document workflows and meet deadlines independently
Skills
Veeva QualityDocs
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